BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENVISTA IOL

    MDR report key: 4840764 · Received June 10, 2015

    Report

    Report Number
    1313525-2015-01578
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Report Date
    May 20, 2015
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS AND LENS VIAL WERE NOT RETURNED FOR EVALUATION. THE LOT HISTORY RECORD WAS REVIEWED AND THERE WERE NO NON-CONFORMITIES OR ANOMALIES RELATED TO THIS COMPLAINT. BASED ON THE INFORMATION CURRENTLY AVAILABLE THE MOST LIKELY ROOT CAUSE OF THE EVENT IS RELATED TO A LEAKING LENS VIAL. THE TYPE OF LENS ASSOCIATED WITH THIS REPORT HAS BEEN DISCONTINUED AND A NEW (REDESIGNED) VIAL WAS IMPLEMENTED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LENS WAS DRY. THERE WAS NO LIQUID IN THE LENS VIAL. THE LENS WAS NOT USED. THIS EVENT OCCURRED WITH TWO LENSES. THIS REPORT REFERS TO LENS 1 OF 2. REFERENCE MDR # 1313525-2015-01579 FOR LENS 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377778 ENVISTA IOL LENS, INTRAOCULAR HQL BAUSCH & LOMB MX60 3441621

    Patients

    Seq Age Sex Outcome Treatment
    1